URTI - Viral Upper Respiratory Tract InfectionNCT07033754
A Study to Assess the Effect Probiotic Supplement on Immune Health in Teachers Prone to Upper Respiratory Tract Infection
A study testing Propionibacterium freudenreichii P.UF1 and Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia in people with URTI - Viral Upper Respiratory Tract Infection, run by Vedic Lifesciences Pvt. Ltd. at 6 sites in India.
Trial summary
The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical studydesigned to assess the effects of IP on immune health in teachers prone to URTI. Approximately 179individuals aged between 18 and 50 years will be screened. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- URTI - Viral Upper Respiratory Tract Infection
- What is being tested?
- Propionibacterium freudenreichii P.UF1 and Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 6 sitesIndia
- Study dates
- 25 Jun 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals ready to give voluntary, written informed consent to participate in thestudy.
- Male and female teachers aged between 18 to 50 years' (both values included) withmoderate physical activity level as per International Physical Activity Questionnaire -Short Form (IPAQ - SF).
- Individuals with body mass index (BMI) between 22 kg per m2 to 32.0 kg per m2
- High susceptibility to URTIs at least once every three months for last 1 year (at least 4to 6 episodes in a year).
- Individuals who have active URTI episode at screening defined as "those having a scoreof less than equal to 5 for at least 2 symptoms out of runny nose, plugged nose,sneezing, sore throat, scratchy throat, cough or head congestion on the WURSS-21".
- Commitment to adhere to routine diet and physical activity.
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- Willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics andfiber supplements, probiotics, Echinacea, fish oil, vitamin E, etc.) at least 1 one monthprior to screening.
- Willing to discontinue sleep medications at least 1 month prior to screening and duringthe entire study duration.
- Individuals willing to complete all study-related and clinical study visits as per theprotocol.
Who cannot join
- Individuals with a history of rhinitis medicamentosa, anatomical nasal obstruction ordeformity, nasal reconstructive surgery, etc
- Individuals taking prebiotics, probiotics, synbiotics or post-biotics supplements 1 monthprior to screening.
- Individuals with known sensitivity to the investigational products or any excipients ofthe product.
- Individuals with any clinically significant abnormalities of the upper respiratory tract(such as stridor, laryngomalacia, etc.).
- Individuals suffering from lower respiratory tract infection (LRTI) of any origin.
- Any individual not willing to follow the abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, and vapor rub, etc.
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- Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose lessthan equal to 126 mg per dL.
- Individuals with uncontrolled hypertension on medication and with systolic bloodpressure less than 140 and or diastolic blood pressure less than equal to 90 mmHg.
- Individuals who are unable to abstain from herbal or dietary supplements for URTI throughout the study period.
- Vaccination against influenza or swine flu within 90 days prior to screening.
- Those who have taken or should be taking or are taking antibiotics, antivirals, steroids,nasal decongestants, antihistamines, NSAIDs, or other medications that are expected to alleviate cold symptoms within two weeks prior to screening.
- History of any significant neurological and psychiatric condition which may affect theparticipation and inference of the study's end points.
- Participation in other clinical trials in last 90 days prior to screening
- Individuals with substance abuse problems (within 2 years) defined as: a) Use ofrecreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobaccoor smoking dependence. b) High-risk drinking as defined by consumption of 4 or morealcohol containing beverages on any day or 8 or more alcohol containing beverages perweek for women and 5 or more alcohol-containing beverages on any day or 15 or morealcohol containing beverages per week for men.
- Individuals who have clinically significant following severe illness
- Females who are pregnant/planning to be pregnant or lactating or taking any oralcontraceptives.
- Any condition that could, in the opinion of the investigator, preclude the individual'sability to successfully and safely complete the study or that may confound studyoutcomes
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
India6 sites
Lifeline Clinicand Diagnostics
Nashik, Maharashtra, 422010
Madhumeh Clinic
New Delhi, National Capital Territory of Delhi, 110091
Dr Ajay Gupta, MBBS MD, 98711 34389, drajaykumargupta@gmail.com
AMF MorayaMultispecialityHospital
Pune, Maharashtra, 411033
Dr Avinash Wachasundar, MBBS MD, 9822046072, avinashwacha@gmail.com
ENT and VertigoClinic
Pune, Maharashtra, 411045
Dr Rupali Gulavani, MBBS MD, 9923108585, drrupalivg@gmail.com
Nand Hospital
Vadodara, Gujarat, 390007
Dr Niraj chawda, MBBS MD, 9909007791, nirajchawdaicr@gmail.com
Janta Hospital &MaternityCentre
Varanasi, Uttar Pradesh, 221011
Dr Manoj Kumar Pal, MBBS MD, 9198677778, manojpalvns@gmail.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Study to Assess the Effect of ProGenr8™ (Probiotic Supplement) on Immune Health in Teachers Prone to Upper Respiratory Tract Infection (URTI)
The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical studydesigned to assess the effects of IP on immune health in teachers prone to URTI. Approximately 179individuals aged between 18 and 50 years will be screened. Considering a screen failure of 20%,approximately 144 individuals will be randomized in a ratio of 1:1 to receive either the active orplacebo. The study will have at least 100 completed participants i.e. 50 participants in each studyarm after accounting for a dropout/withdrawal rate of 30% at the end of the study. The interventionand follow-up duration for all the study participants will be 120 days.
- Being tested
- Propionibacterium freudenreichii P.UF1, Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propionibacterium freudenreichii P.UF1Dietary supplement
one capsule once a day with/beforebreakfast for 120 days
Microcrystalline cellulose, calciumcarbonate, Mg Stearate, SylysiaDietary supplement
one capsule once a day with/beforebreakfast for 120 days
| Study group | Role | What they receive |
|---|---|---|
| Propionibacterium freudenreichii P.UF1 | Active comparator | one capsule once a day with/beforebreakfast for 120 days Receives: Dietary Supplement: Propionibacterium freudenreichii P.UF1 |
| Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia | Placebo comparator | one capsule once a day with/beforebreakfast for 120 days Receives: Dietary Supplement: Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Measure the effect of the 120 days' administration of IP on %population having one or more episodes of URTI during the study duration asassessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire as compared to baseline and placebo.
The WURSS-21 includes nine items assessing the impact of the URTI episode on an individual's quality of life i.e., the ability to think clearly, sleep well, breathe easily, exercise, work inside and outside the home, accomplish daily activities, interact with others and live one's personal life. All the items will be scored on an 8-point Likert scale ranging from 0 which depicts "absent or no impairment" to 1 (very mild), 3 (mild) 5(moderate), and 7 (severe). Participants will be instructed to fill this questionnaire whenever they have a URTI episode on all days throughout the study. An average of all WURSS-21 QoL scores will be calculated for every episode and considered to analyze the change in QoL as compared to baseline and placebo.
Measured: Day 30,Day 90 & Day 120
Secondary outcomes (3)
To Measure the effect of IP in comparison to baseline and placebo on-Severity of the URTI episodes as assessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire(WURSS-21)
In WURSS-21 All the items will be scored on an 8-point Likert scale ranging from 0, which depicts "absent or no impairment", to 1 (very mild), 3 (mild), 5 (moderate), and 7 (severe).43 The global score of WURSS-21 (question no. 1-19) ranges from 0-133 per day. Higher scores represent higher severity
Measured: From Date of Randomization upto 120 days
To Measure the effect of IP in comparison to baseline and placebo on-Severity of the URTI episodes as assessed by Number of URTI episodes
the number of URTI episodes (frequency) and proves to be beneficial in individuals suffering from frequent URTI episodes
Measured: From Date of Randomization upto 120 days
To Measure the effect of IP in comparison to baseline and placebo on -Body composition (Fat tissue, lean mass, fat free mass) as assessedby Dual Energy X-ray Absorptiometry -Gut microbiome analysis as assessed by Next Generation Sequencing
Dual Energy X-ray Absorptiometry Scans can assess fat content and total body composition with a high degree of precision that is comparable to hydrostatic weighing The investigation of the gut microbiota in a culture-independent manner has been made possible by next-generation sequencing technology, which has provided insights into the intricate and little-understood interactions between the gut microbiome and its host
Measured: Day 0 and Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start25 Jun 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion20 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for URTI - Viral Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Double-blind, Placebo-controlled, Parallel Clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033754
- Sponsor's protocol ID
- SB/240701/IP/URTI
- Status last verified
- Feb 2025
- First submitted
- 6 Mar 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Study to Assess the Effect of ProGenr8™ (Probiotic Supplement) on Immune Health in Teachers Prone to Upper Respiratory Tract Infection (URTI)
- ClinicalTrials.gov ID
- NCT07033754
- Acronym / sponsor ID
- SB/240701/IP/URTI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical studydesigned to assess the effects of IP on immune health in teachers prone to URTI. Approximately 179individuals aged between 18 and 50 years will be screened. Considering a screen failure of 20%,approximately 144 individuals will be randomized in a ratio of 1:1 to receive either the active orplacebo. The study will have at least 100 completed participants i.e. 50 participants in each studyarm after accounting for a dropout/withdrawal rate of 30% at the end of the study. The interventionand follow-up duration for all the study participants will be 120 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A Randomized, Double-blind, Placebo-controlled, Parallel Clinical study
| Arm | Type | Receives |
|---|---|---|
| Propionibacterium freudenreichii P.UF1 | Active comparator | Dietary Supplement: Propionibacterium freudenreichii P.UF1one capsule once a day with/beforebreakfast for 120 days |
| Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia | Placebo comparator | Dietary Supplement: Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysiaone capsule once a day with/beforebreakfast for 120 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Individuals ready to give voluntary, written informed consent to participate in thestudy.
- Male and female teachers aged between 18 to 50 years' (both values included) withmoderate physical activity level as per International Physical Activity Questionnaire -Short Form (IPAQ - SF).
- Individuals with body mass index (BMI) between 22 kg per m2 to 32.0 kg per m2
- High susceptibility to URTIs at least once every three months for last 1 year (at least 4to 6 episodes in a year).
- Individuals who have active URTI episode at screening defined as "those having a scoreof less than equal to 5 for at least 2 symptoms out of runny nose, plugged nose,sneezing, sore throat, scratchy throat, cough or head congestion on the WURSS-21".
Key exclusion criteria (17 listed)
- Individuals with a history of rhinitis medicamentosa, anatomical nasal obstruction ordeformity, nasal reconstructive surgery, etc
- Individuals taking prebiotics, probiotics, synbiotics or post-biotics supplements 1 monthprior to screening.
- Individuals with known sensitivity to the investigational products or any excipients ofthe product.
- Individuals with any clinically significant abnormalities of the upper respiratory tract(such as stridor, laryngomalacia, etc.).
- Individuals suffering from lower respiratory tract infection (LRTI) of any origin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propionibacterium freudenreichii P.UF1one capsule once a day with/beforebreakfast for 120 days | Dietary supplement | Propionibacterium freudenreichii P.UF1 |
| Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysiaone capsule once a day with/beforebreakfast for 120 days | Dietary supplement | Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia |
Primary outcome
To Measure the effect of the 120 days' administration of IP on %population having one or more episodes of URTI during the study duration asassessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire as compared to baseline and placebo.
Time frame: Day 30,Day 90 & Day 120
The WURSS-21 includes nine items assessing the impact of the URTI episode on an individual's quality of life i.e., the ability to think clearly, sleep well, breathe easily, exercise, work inside and outside the home, accomplish daily activities, interact with others and live one's personal life. All the items will be scored on an 8-point Likert scale ranging from 0 which depicts "absent or no impairment" to 1 (very mild), 3 (mild) 5(moderate), and 7 (severe). Participants will be instructed to fill this questionnaire whenever they have a URTI episode on all days throughout the study. An average of all WURSS-21 QoL scores will be calculated for every episode and considered to analyze the change in QoL as compared to baseline and placebo.
3 secondary outcomes
To Measure the effect of IP in comparison to baseline and placebo on-Severity of the URTI episodes as assessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire(WURSS-21)
Time frame: From Date of Randomization upto 120 days
To Measure the effect of IP in comparison to baseline and placebo on-Severity of the URTI episodes as assessed by Number of URTI episodes
Time frame: From Date of Randomization upto 120 days
To Measure the effect of IP in comparison to baseline and placebo on -Body composition (Fat tissue, lean mass, fat free mass) as assessedby Dual Energy X-ray Absorptiometry -Gut microbiome analysis as assessed by Next Generation Sequencing
Time frame: Day 0 and Day 120
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propionibacterium freudenreichii P.UF1 and Microcrystalline cellulose, calciumcarbonate, Mg Stearate, Sylysia in people with URTI - Viral Upper Respiratory Tract Infection, run by Vedic Lifesciences Pvt. Ltd. at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Sanjay Vaze, MBBS (8655670964, sanjay.v@vediclifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Measure the effect of the 120 days' administration of IP on %population having one or more episodes of URTI during the study duration asassessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire as compared to baseline and placebo. (time frame: Day 30,Day 90 & Day 120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.